Description
Release form
Injection
Pharmacological action
Omniscan enhances contrast and facilitates visualization of abnormal structures or formations in the central nervous system.
Pharmacokinetics
Quickly distributed in extracellular fluid, does not cross the intact blood-brain barrier. The volume of distribution is equivalent to the volume of extracellular fluid. The half-life is approximately 4 minutes. No protein binding detected. It is almost completely excreted through the kidneys unchanged (glomerular filtration). After 4 hours after intravenous injection, about 85% of the dose passes into the urine, after 24 hours – 95 98%. The half-life is about 70 minutes. With the introduction of the drug in the dose range from 0.1 to 0, 3 mmol / kg, no dependence of the pharmacokinetic parameters on the dose.
Contraindications
severe renal impairment (glomerular filtration rate less than 30 ml / min / 1.73 m2)
liver transplant surgery
hypersensitivity to the drug.
Caution is advised to use the drug in case of anemia, especially with sickle cell, hemolytic hemoglobinopathy, liver failure in infants and children under the age of 1 year (due to insufficiently developed kidney function).
Use during pregnancy and lactation
Use of Omniscan during pregnancy is possible only in cases of emergency. During lactation – breastfeeding should be stopped at least 24 hours before the administration of gadodiamide and resumed no earlier than 24 hours after its administration.
In experimental studies on rodents, it was shown that gadodiamide does not affect fertility and does not have a teratogenic effect.
Special instructions
Omniscan should not be used in patients with impaired renal function with a glomerular filtration rate of less than 30 ml / min. Gadodiamide should be administered under conditions that allow, if necessary, immediate intensive care.
Composition
active substance: gadodiamide (non-ionic paramagnetic compound) at a concentration of 0, 5 mmol
excipients: sodium caldiamide, sodium hydroxide 1M or hydrochloric acid 1M, water for injection.
Dosage and administration
Intravenously, once.
Contrasting the central nervous system during MRI
For adults and children of all ages, including newborns, with a body weight of less than 100 kg, the recommended dose is 0.1 mmol / kg (equivalent to 0.2 ml / kg) with a body weight of more than 100 kg, 20 ml of Omniscan is usually sufficient.
In cases of suspected metastatic brain damage in adults with a body weight of up to 100 kg, the drug may be administered in a double or triple dose – up to 0.3 mmol / kg (0. 6 ml / kg) with a body weight of more than 100 kg, usually 60 ml of the drug is sufficient. In the case of mixed results of the study after contrast enhancement by Omniscan at a dose of 0.1 mmol / kg, a repeated bolus injection of the drug is possible over the next 20 minutes at a dose of 0.2 mmol / kg (0.4 ml / kg) in order to obtain additional diagnostic information.
Full body contrast
For adults with a body weight of up to 100 kg, the recommended dose is usually 0.1 mmol / kg (0.2 ml / kg), in some cases 0.3 mmol / kg (0.6 ml / kg) with a body weight of more than 100 kg – 20 ml, in some cases – 60 ml of the drug is usually enough to ensure diagnostically adequate contrast.
For children over 6 months of age, the recommended dose is 0.1 mmol / kg (0.2 ml / kg).
Angiography
For adults, the recommended dose is usually 0.1 mmol / kg (0.2 ml / kg)
For stenosis of the abdominal and iliac arteries, the drug is used in a higher dose – up to 0.3 mmol / kg (equivalent to 0.6 ml / kg), which allows you to get additional diagnostic information.
Side effects
On the part of the body as a whole: fever, chills.
Allergic reactions: urticaria, itching, sore throat, anaphylactoid reactions rarely – anaphylactic shock.
From the digestive system: loss of appetite, belching, abdominal pain, diarrhea, nausea, vomiting.
From the side of the central nervous system and peripheral nervous system: dizziness, headache, anxiety, mental disorders, ataxia, impaired coordination of movements, paresthesia, tremors, loss of consciousness (up to the development of deep coma), drowsiness rarely – convulsions (up to the development of epileptic status) .
On the part of the sensory organs: a change in taste and smell, visual impairment, tinnitus.
From the urinary system: there are indications of the possible development of nephrogenic systemic fibrosis (NSF) in patients with severe impaired renal function (glomerular filtration rate less than 30 ml / min / 1.73 m2).
Local reactions: local soreness or a feeling of fullness at the injection site.
Other: asymptomatic decrease in serum iron (within 8 to 48 hours after drug administration), idiosyncrasy, arthralgia, myalgia, hyperemia of the skin, increased sweating.
Overdose of
Symptoms: may increase the manifestation of the described side effects.
Treatment: symptomatic treatment. Gadodiamide is removed from the body by hemodialysis (in patients with impaired renal function and receiving large doses).
Storage Conditions
In a dark place at a temperature not exceeding 25 ° C.
Term hodnosty
3 years
active substance
gadodiamide
drugstore conditions
drugstore prescription
lekarstvennaja form
Solution for infusion
Appointment
Adults doctor’s prescription
Possible product names
Omniscan 0.5 mmol / ml 20 ml No. 10 fl
OMNISCAN 0.5 MMOL / ML 20ML N10 FLAC
OMNISCAN 0.5 MMOL / ML 20ML FLAC
Omniscan 0.5 mmol. 20 ml x 10
Omniscan 0. 5 mmol / ml solution for iv administration. 20ml fl. X10 B
GE Helskea AS, Norway
